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Clinical Trials/NCT03183011
NCT03183011
Unknown
Not Applicable

Cardiac Magnetic Resonance Imaging After Cardiac Resynchronization Therapy

Kenneth Bilchick, MD1 site in 1 country40 target enrollmentNovember 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure, Systolic
Sponsor
Kenneth Bilchick, MD
Enrollment
40
Locations
1
Primary Endpoint
CRT Response
Last Updated
8 years ago

Overview

Brief Summary

This study is evaluating how MRI after CRT can provide key insights regarding LV function, structure, and mechanics resulting from CRT in patients with or without LV scar and inform optimal pacing strategies. The expected accurate and reproducible response assessment with cardiac MRI has important implications for evaluating CRT outcomes in clinical trials, and the insights from the post-CRT MRI promise to improve implementation of CRT.

Detailed Description

We are performing a study of 40 patients with current accepted indications for CRT and no MRI contraindications. These patients will have a pre-CRT MRI and another post-CRT MRI 6 months after the CRT procedure. Echocardiography, cardiopulmonary exercise testing, symptom assessment, and laboratory testing are also performed before and after CRT. Modifications to the post-CRT MRI protocol include the use of gradient echo cine imaging rather than steady state free precession imaging, application of wideband imaging to the LGE acquisitions, and strain imaging with cine Displacement Encoding with Stimulated Echoes (DENSE) tailored for device patients.

Registry
clinicaltrials.gov
Start Date
November 1, 2016
End Date
December 31, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Kenneth Bilchick, MD
Responsible Party
Sponsor Investigator
Principal Investigator

Kenneth Bilchick, MD

Associate Professor

University of Virginia

Eligibility Criteria

Inclusion Criteria

  • Chronic systolic HF
  • LVEF 35% or less
  • Guideline-based class I or IIa indication for CRT
  • 25 and 85 years old
  • Predominantly in sinus rhythm
  • GFR ≥ 40 ml/min/1.73m2\* \*Contrast will not be given for the 6-month follow-up scan if the GFR falls to \< 40 ml/min/1.73m2.

Exclusion Criteria

  • Inability to provide informed consent
  • Pregnancy
  • Presence of metal embedded in the body due to prior accident or injury, as documented by skull films or other imaging
  • Preexisting pacemaker or defibrillator prior to enrollment
  • Cerebral aneurysm clips; 6) cochlear implants
  • Other metallic implants (prior to enrollment) known to be contraindications to MRI
  • Severe claustrophobia
  • Acute kidney injury
  • Acute renal failure or chronic kidney disease with GFR \< 40 cc/min
  • Liver transplant

Outcomes

Primary Outcomes

CRT Response

Time Frame: 1 year

CRT Response

Study Sites (1)

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